AnHeart Therapeutics and Innovent Biologics, Inc. announced the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Priority Review Designation for the New Drug Application (NDA) of Taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs. The CDE accepted the NDA in November 2023. Taletrectinib is being evaluated for the treatment of ROS1-positive NSCLC patients in two Phase 2 trials, TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global pivotal trial.

In March 2022, taletrectinib was granted Breakthrough Therapy Designation by the CDE of China's NMPA for the treatment of adult patients With advanced or metastatic ROS1 TKIs as well as those who have not previously been treated by ROS1 TKIs (TKI-naive). Taletrectinib has also been granted Breakthrough Therapy Designation in the United States for the treatment of ROS1 -positive NSCLC by the U.S. Food and Drug Administration (FDA). In June 2021, AnHeart and Innovent entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

About ROS1-Positive NSCLC in China: More than one million people globally are diagnosed with NSCLC annually, the most common form of lung cancer. Up to 35% of people newly diagnosed with metastatic ROS1- positive NSCLC have tumors that have spread to their brain (brain metastases), increasing up to 55% for those whose cancer has progressed following initial treatment.